There is an increasing use of long-term contraceptives, of which one type is a subdermal implant in the form of a rod that releases contraceptive hormone, until it needs to be removed or replaced with a new rod. For example, Nexplanon [Schering-Plough Limited/Merck, Sharp & Dohme Limited (MSD) US] is a subdermal implant indicated for use as a long-term contraceptive for women. It entered the European market in 2010, replacing Implanon (available in Europe and SE Asia since 1998, and approved in the US in 2006), the most widely used implantation system in the world, marketed in 32 or more countries throughout the world. The implant of both Implanon and Nexplanon is a 4 cm long, 2 mm diameter non-biodegradable ethylene vinyl acetate (EVA) copolymer core, containing 68 mg of the synthetic progestin etonogestrel, surrounded by a rate-controlling EVA copolymer membrane. The implant must be replaced or removed 3 years after insertion.
Other contraceptive implants are Jadelle, 43 mm long, 2.5 mm diameter (2 rods), lasts 5 yrs, and Sino-Implant II, 44 mm long, 2.4 mm diameter (2 rods), lasts 4 yrs.
Increased focus on the benefits of long-acting, reversible contraception has spurred an increase in CI insertions in recent years, both in industrialised and developing countries. On a global scale, multiple campaigns have been launched to meet UN Millenium Goals 4 and 5, i.e. reduction of maternal and child mortality, and a steep increase in CI procurement is expected for the foreseeable future. Within few years millions of women will need to have their CIs removed on an annual basis.
Since CIs were introduced to the commercial market in the early 1980s, implant manufacturers have focused intense efforts on making insertion of CIs easier. For instance, a unique, preloaded disposable applicator developed for Nexplanon ensures “fail proof” and efficient subdermal insertion of the implant. CI removals, on the other hand, have largely been left untouched and at the mercy of the various service providers. The CI removal procedure recommendations have remained essentially unchanged for 40 years, relying on general surgical skills from the service provider.
While contraceptive implant (CI) insertion is easily managed through the use of specialsed introducer trocars, CI removal is a complex task that requires specialist training. There exists no standardised method for CI removal, and no dedicated removal devices are available on the global market. Currently, CIs are removed using scalpels and forceps and rely on the general surgical skills of the service provider. Thus, the procedure is highly variable in duration and often cumbersome, both for the patient and for the clinician. The complex current CI removal procedure is a major impediment to a desired increase of CI use. Introducing a simple, safe and effective CI removal procedure could improve patient care, be cost-effective for CI service providers and increase access to complete CI care.
All available research shows that the procedure length of the current CI removal procedure is highly variable and heavily reliant on individual operator skills.